The disclosed invention was funded, at least in part, by NASA.
The present invention relates generally to the creation of solutions for intravenous administration. More specifically, the present invention relates to the creation on site, remote from sterile environments, of parenteral (intravenous) solutions.
Of course, it is common practice to administer many solutions, medicaments, agents, and the like to a patient intravenously (parenterally). These solutions are typically housed in containers, that are constructed from flexible plastic or glass. Typically, these parenteral solutions are housed in containers having volume capacities of at least one liter, referred to as large volume parenteral containers.
Large volume parenteral containers typically include solutions such as saline, dextrose, or lactated Ringer's. Although these solutions can be administered to a patient alone, typically, an agent or medicament is added to the parenteral solution and the resultant product is then administered intravenously to the patient. Accordingly, the container includes a medication or additive port allowing an agent to be added to the container. Additionally, an access port is provided for accessing the container.
In use, the container is suspended and an IV line or other access means is utilized to access the container through the access port. Typically, the IV line includes a spike that is designed to pierce a membrane in the access port establishing fluid communication. A second end of the IV line is then directly inserted into the patient or coupled to a Y-site that provides fluid communication with the patient.
There are many situations wherein due to storage space and/or weight limitations, or other concerns, it is not possible, or practical, to maintain an adequate inventory of parenteral solutions that may be necessary. For example, space shuttles, or the envisioned space stations, have severe restrictions on the weight and volume of items that are stored or transported. Although it may be desirable to stock a number of intravenous solutions for use in an emergency, or for medical treatment, it is not possible due to weight and/or storage limitations to inventory a large volume of such solutions in many situations. Likewise, in other situations, such as in a combat zone, it may not be possible to transport the necessary parenteral solutions.
Still further, even within health care facilities, cost and storage limitations may limit the inventory of product that is purchased and stored. Therefore, it may be desirable to compound on the premises the necessary parenteral solutions.
Although it is known in certain applications to compound and/or reconstitute drugs prior to use, typically such reconstitution processes are performed in sterile conditions, for example, under a laminar flow hood. Such sterile conditions would not typically be present in certain situations wherein there exists severe weight and storage limitations, e.g., the aforementioned space station or combat zone. Likewise, current machinery for creating large volume parenteral products not only require sterile conditions, but also is quite bulky and heavy and not easily transportable.
Furthermore, typically reconstitution processes usually require either a prepackaged intravenous solution to assist in the reconstitution process, i.e., a bag of saline or dextrose, or can only be utilized to make small volumes of solutions. These processes therefore are not conducive to the creation of large volume parenteral containers.